Neoadjuvant Therapy for Stomach Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Metastatic disease, Solitary kidney, Polyneuropathy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Trial Summary

What is the purpose of this trial?

This phase I trial tests the safety, side effects studies chemotherapy followed by chemotherapy at the same time as radiation therapy (chemoradiation) before surgery (neoadjuvant) in treating patients with stage gastric (stomach) or gastroesophageal junction cancer . Chemotherapy drugs, such as docetaxel, oxaliplatin , leucovorin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy and chemoradiation before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.

Research Team

Dayssy A Diaz Pardo, MD, MS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with certain stages of stomach or gastroesophageal junction cancer, who are fit enough for surgery and chemotherapy. They should not have distant spread of cancer, severe neuropathy, or only one working kidney in the radiation area.

Inclusion Criteria

My cancer is early stage and has not spread to lymph nodes.

I am eligible for surgery.

I have had or am recommended to have special scans to check my cancer stage before joining.

Exclusion Criteria

My cancer has spread to distant parts of my body.

My nerve damage does not severely limit my daily activities.

I have only one working kidney that might be affected by radiation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Patients receive FLOT or FOLFOX chemotherapy every 2 weeks for 4 cycles

8 weeks

Neoadjuvant Chemoradiation

Patients undergo radiation therapy in 25 fractions over 5 weeks and receive fluorouracil or capecitabine

5 weeks

Surgery

Patients undergo surgical resection according to tumor location and per surgeon expertise

4-8 weeks after chemoradiation

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• Capecitabine
• Docetaxel
• Fluorouracil
• Leucovorin
• Oxaliplatin
• Radiation Therapy
• Surgical Procedure

Trial Overview The study tests if giving chemotherapy (with drugs like docetaxel and oxaliplatin) followed by chemoradiation before surgery can safely shrink tumors in patients with gastric or gastroesophageal junction cancer.

Participant Groups

Group I: Treatment (chemotherapy, chemoradiation, surgery) Experimental Treatment 7 Interventions

NEOADJUVANT CHEMOTHERAPY: Patients receive FLOT chemotherapy consisting of docetaxel intravenously (IV) , oxaliplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on day 1 or FOLFOX chemotherapy consisting of oxaliplatin IV and leucovorin IV, and fluorouracil IV continuously over 24 hours on days 1 and 2. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. NEOADJUVANT CHEMORADIATION: Within 4 weeks after completing neoadjuvant chemotherapy, patients undergo radiation therapy in 25 fractions over 5 weeks. Patients also receive either fluorouracil IV continuously for 24 hours on days 1-5 or capecitabine orally (PO) twice daily (BID) on days 1-5. Cycles repeat weekly for 5 weeks in the absence of disease progression or unacceptable toxicity. SURGERY: Within 4-8 weeks after neoadjuvant chemoradiation, patients undergo surgical resection according to tumor location and per surgeon expertise.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+